Composition with Anti-Inflammatory, Protein Synthesizing, Enzyme Deficiency Activating Genetic Therapy and Anti-Cancer Activity and Methods of Use

ABSTRACT

A composition for treating damaged tissue and promoting healthy tissue growth, healing and tissue regeneration, wherein said composition comprises an extracellular matrix compound, a surface-active lipid, one or more enantioinerically pure L-amino acids or glycine, a hydrophilic surfactant with a high HLB, as well as vitamins, minerals or trace elements. Not only does it maintain good health, but the components are non-intrusive, bio-safe, non-coalescent and can mimic normally occurring stem-cells within a body. When applied to diseased tissues, the subject compositions can stimulate, facilitate, and accelerate protein synthesis for the regeneration of diseased organs and tissues. The healing efficacy of these tissue components gives us further appreciation of the protective action of human tissue over and above and other than the immune protective system or perhaps an integral component part of the immune system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 10/765,664, filedJan. 26, 2004, now U.S. Pat. No. 7,790,678, which is aContinuation-in-Part of U.S. Ser. No. 10/752,298, filed Jan. 5, 2004,now abandoned, which claims the benefit of 60/437,939, filed Jan. 3,2003. This application also a continuation of U.S. Ser. No. 10/765,664,filed Jan. 26, 2004, now U.S. Pat. No. 7,790,678, which claims thebenefit of U.S. Ser. Nos. 60/442,278, filed Jan. 24, 2003; 60/447,779,filed Feb. 13, 2003; 60/448,003, filed Feb. 18, 2003; and 60/448,497,filed Feb. 19, 2003. This application is a continuation of U.S. Ser. No.10/765,664 (now U.S. Pat. No. 7,790,678), filed Jan. 26, 2004 which is aContinuation-in-Part of U.S. Ser. No. 09/639,859, filed Aug. 16, 2000,now U.S. Pat. No. 6,974,796, which claims the benefit of U.S. Ser. No.60/149,338, filed Aug. 17, 1999. These applications are all herebyincorporated by reference in their entireties, including all figures,formulae, references and tables.

BACKGROUND OF INVENTION

In prior art, the treatment of disease centers around the position to“kill” as if we are trying to kill an infectious agent. This isexemplified by the discovery that platinum kills bacteria. Many of theleading cancer products of prior art are derivatives of platinum (orsimilar toxic products derive from the periodic table) such as but notlimited to cis-platinum and carbo platinum.

It would be desirable to surmount the awesome challenges of diseasetreatment by restructuring diseased tissue with biochemical andbiophysical components of normal tissue, which have the associatedfeatures of restructuring, healing and regeneration of organs and tissueto their normal status. This series of inventions mimic, in analogfashion, human tissue and thereby draws from normal molecular structuredbiochemicals with required biophysical function and from pharmacopoeiafrom major industrialized countries.

This has been so accomplished with results which include a therapeuticstem cell like composition which by simulating, accelerating andfacilitating stem cell healing increases the tissue regenerationcapacity of the patient's stem cells, thereby reversing diseases ofgreat severity and complication. For example, organ failure can bereversed without resorting to such extreme measures of desperation andgravity, including organ transplant or tissue graft. As result of thisunique focus and sourcing the associated risks and objections ofdependency upon the use of human tissue and human embryonic tissue isnot required.

This inventor has observed that tissue has a self healing effectpromoting tissue healing and tissue regeneration. Not only does itmaintain good health but also it has been observed that the patient'sblood is withdrawn from patients with a leg ulcer and the blood is thenapplied to the ulcer the blood is shown to have healing qualities.Cartilage placed in a wound also promotes and accelerates wound healing.The anabolic biochemical and biophysical essence and equivalence oftissue has been found in these embodiments to have the same healing andtissue regeneration pharmacologic qualities, when devoid of genetic DNAmismatch and other catabolic factors including the catabolic effects ofmicroorganism overgrowth that lacks pro-biotic qualities. The healingefficacy of these tissue components gives us further appreciation of theprotective action of human tissue over and above (and other than) theimmune protective system or perhaps an integral component of the immunesystem.

The components are most effective when freely available to the metabolicstream and thereby overcome the disease producing debris of disease andcrystal seeding effect obstructive and foreign to the metabolic stream.Mismatching is further assured by adherence to tissue equilibriumparticularly applied here the hydrophilic/lipophilic balance HLBequilibrium. Therapeutically, through polar surface active lipidsurfactants permits the tissue to maintain the unique required strata ofalternation of hydrophilic with hydrophobic components such as lipids.

This strata is analog to the earth's strata exemplified by thehydrophobic nucleus surrounded by hydrophobic cytoplasm furthersurrounded by lipophilic cell membrane and the strata is finalized witha hydrophilic extracellular matrix. The same patterned alternate stratacan be seen in the biomolecular macromolecules of proteins with thelipophilic central core derive primarily from the essential amino acidssurrounded by the hydrophilic periphery of primarily nonessential aminoacids further forming and attracting a clathrate cage of structuredordered nonrandom non-liquid water accounting for the alpha helix orbeta sheet folding and associated and dependent biologic structure andfunction.

It has been found in these embodiments that high HLB surfactanttreatment alters the allergenicity of cat protein's 3-D structure andpathogenicity.

These same biophysical features provide the opportunity to use highlyhydrophilic surfactants with their high surfactant packing parameters toprovide, through hydrogen bonding, a clathrate cage of structured waterand energy input and change in entropy that enhances refolding of themisfolded proteins and protein derangements and aggregates that arepathophysiologic and pathogenetic basis for diseases such as Alzheimer'sdisease, Parkinson's disease, Mad Cow disease and its human equivalenttransmissible spongiform encephalopathy. It is this tissue essence andthis biochemical and biophysical molecular engineering that has resultedin therapeutic efficacy combined with bio-safety offering therapeuticopportunities that have been otherwise not forthcoming.

The prior art teaches a passive relationship, between the genetic codeand amino acid structures. However, the prior art does not teach the useof therapeutic compositions for actively enhancing and normalizingfunctional aspects of the cell nucleus and cytoplasm in disease tostimulate, facilitate, and accelerate protein synthesis in diseasedorgans and tissues.

Therapeutic stimulant, activator and substrate compositions that providetherapy for hereditary diseases and conditions of hereditarypre-disposition were disclosed in provisional Patent Application Ser.No. 60/149,338, filed Aug. 17, 1999 and are described in co-pending,U.S. patent application Ser. No. 10/269,613, filed Oct. 11, 2002 (eachof which is hereby incorporated by reference in their entireties). Asthere disclosed, molecular monomers having alpha amino- and alphacarboxylic groupings similar in molar ratio of the component amino acidmonomers in human tissue and in accordance with the specific code of the20 amino acids of human tissue can be used for the treatment ofdiseases.

This unique drug discovery technology and characteristics of therapeuticsynthetic stem cell-like composition is unique to the prior art is ahealing tissue regenerative therapy and has been shown to be effectivein averting organ graft in the replacement of disease ravaged tissuewhether inflammatory, acute, chronically inflammatory, degenerative,neoplastic or genetic pathogenesis or etiologic on the basis ofmimicking and analog model of human and mammalian tissue. This anabolictissue copy basis is not only a biochemical copy, but also a functionalbio-physical model copy of normal tissue function, with meticulousavoidance of catabolic components, derived from a unique biologicperiodic table. The subject composition also permits reorganization asif the disease were analog to a “bankruptcy” major deficiency withreplenishment not only of the tissue, but even of its trace elements,vitamins and minerals. Additionally the diseased organ or tissuesecretions also represent a biochemical and biophysical copy fortherapeutic normalization of these secretions.

In producing these copies we have also copied the fluidity of functionby mimicking and preparing an analog copy and therefore normalizing thehydrophilic lipophilic (HLB) equilibrium balance, with HLB (withintramolecular OH2/CH2 ratio of these embodiments exemplified byintramolecular composition Tween 80) surfactant energy input andassociated change in entropy along with any defective human andmammalian tissue equilibria.

In so doing, not only the tissues, cells but even the microscopic andsub-microscopic structure and functions of the cell organelles undergonormalization of mitosis and apoptosis ideally characterized foranticancer therapy. The further normalization of mitosis includes themitotic organizing centers of centrioles, peri-centriolar clouds,spindles, chromosomes and centromeres (kinetochores) of the chromosomes,acting like seeds of crystallization in conjunction with themicrotubules and associated protein with tubulin tread millingpolymerization. The mitotic associated tubulin protein of themicrotubule has a double origin, the centriolar poles and thechromosome.

This nanogram and picogram pursuit of repair is all based on the atomicand molecular level of human tissue function as illustrated by Component#1, #2, #3, #4. and #5 of the composition of the subject invention.

We find sequential to the foregoing a bio-computer signaling systembased on the semi-conductivity bio-computer inter-molecular, thereforeintercellular and inter-tissue signaling system of all components of #1and #2 and some components of #3. The functional biophysical overlappingof these three components is the polar surface active lipid surfactantintrinsic to these foregoing components of an emulsifier the expansionof biochemical surface area interaction by surfactant packing parametersand emulsion system, and most importantly thereby a control of fluidity,metabolic fluidity, metabolism electrochemical charge buildup andenhancement and signaling based on common semiconductor bio computerfunctionality and obviating, correcting, avoiding crossroads of disease.ECM Component #3 offers the proteoglycans complex aggregate to supportthe colloidal system with similar architectural structural support ofstructured water, viscosity and lubricant effect of the synovialmembrane joints and vitreous helping to hold the respective retina andumbilical blood vessels in place and unobstructed analog to the cellmembrane phospholipids of component #2, with hyaluronidase serving as a“colloidifier” analog to a high HLB emulsifier to adjust or reduce and“thin” viscosity to enhance flow.

This fluidizing effect converts roadblocks of disease such as crystalsof calcium, cholesterol, uric acid, pigment, disease debris andexogenous crystals such as, but not limited to, silica and asbestos, allacting as disease producing microscopic shards or ‘thorns’ sticking inthe metabolic throat and sides of the patient's tissue.

The anti-inflammatory effects associated with all threeanti-inflammatory bio physiologic activities and accompany proteinsynthesis of components one and two (such as lyso-lecithin proteinsynthesis stimulus effects of PC of component two) as but not limited tothe contrasting tetrahedral alpha amino acid non D, Levorotary aminoacids and non-chiral glycine with proteins tissue fits of these tissue20 specific to the genetic code amino acids in sharp contrast to thearomatic benzene ring derivatives that do not fit of other inflammatorydrugs and therefore also interfere with protein synthesis. Medicationside effects are less when co-used with subject composition. Enhancementof enzymatic activity associated with surfactant packing parameters andcompanion increase in vital zeta potential with use of high HLBsurfactants.

The foregoing can be exemplified by non-intrusive, bio-safe,non-coalescent compositions comprise component #1,anabolic-non-dextrorotary (“non-D” L amino acids, including but notlimited to L-amino acids and non-chiral glycine); component #2 (one ormore cell membrane components formed by self-vesiculating surface-activepolar lipids such as but not limited to phosphatidyl choline (PC) thatforms the double layer of the mammalian cell and nuclear membranes), andcomponent #3 (extracellular matrix material such as collagen,proteoglycans, chondroitin sulfate, or mixtures thereof).

These therapeutic compositions are abundantly supplied and areformulated to contain amino acids in amounts that correspond to molarratio of amino acids in a damaged organ, tissue, or protein. The amountsof each component can be adjusted to match the nature of the organ ortissue being treated. In reversing disease through this series ofinventions, major side effects can be greatly minimized with co-use orsole use with these therapeutic compositions.

It is not only in the applied biochemistry and its associatedbiomolecular structures but also the biophysical surfactant functionsincluding surfactant packing parameters and particle charge of thesethree component compartments and particularly the key to this fluiddynamics fluidizing and hydrophilizing at code of osophical therapy(also present in components one and three with the most concentratedsurfactant function in two) can be poignantly modulated even with thechallenge of modulating and thereby normalizing the abnormal mitosis ofcancer through the biophysical function and structure of the polarsurface active lipids in component number two along with maturationfactor of ethylene oxide Tween 80 component never two. The amount ofsurface-active polar lipid to include in the composition can bedetermined by viscosity measurements. Tissue concentration can bemeasured by viscosity (as used in blood serum which normally is 1.12 to1.22 centipoise with upper limit of three). In the case of theintermediate HLB 8 to 11 (as exemplified by PC phosphatidyl choline whenso used) circulation is improved 25% however there is no change inviscosity or the red blood cell sedimentation rate at these HLB rangesbecause of the fact that biophysical functional effects is upon the cellmembrane. With its use the red cell membrane becomes more plastic, andis made more pliable thereby enhancing circulation and oxygenation.

Providing a polar surface active lipid liquid crystal surfactant ofextreme HLB to overcome the disturbed fluid balance and lack of fluidityof the biophysical inertia of the non metabolizable necrotic debris ofthe disease process results in a crystal (such as but not limited tocalcium phosphate crystal where the phosphorylase enzyme which in turnreleases phosphate to produce the insoluble salt deposit of calciumphosphate).

MRI crystalline calcium salts detected by MRI in the coronary artery maymake stress testing not necessary. And biochemical models so derivedfrom the crystallization requirements (as historically in the case outof the x-ray diffraction study of the DNA molecule) may lead to thebiomolecular engineering model of life but the possibility of thedisease variant of life (in contrast to normal model of life) must begiven serious contrasting consideration.

Other intracellular and tissue body deposition responses include thelipid cholesterol crystal found in atherosclerosis and coronary arterydisease whereby the lipid crystal has a melting point of 50 degreeshigher than normal body temperature. Other crystal responses includedpoorly soluble uric acid crystal deposits derived from purine metabolicproducts or exogenous derived silica crystal and asbestos bodies andother difficult to process shards resistant to fluidity necessary fornormal metabolic processing. These perpetuating foreign substancespromote chronic inflammation, chronic granulomatous reactions, and incertain situations (such as but not limited to asbestos) may progress tocancer after a long period of deposition (which may be as long as 20years). In this debris may included poorly attainable or derivableprocessing due to lack of metabolic tools (such as but not limited to inthe case of a carbohydrate and glycogen trapped as polymerized glucoseform of energy not obtainable from glucose because of the lack ofinsulin receptor response as in the case of Type II diabetes ordeficiency of enzymes as in the case of “storage diseases”). In the caseof trans fats, it has been observed to be associated with Type IIdiabetes with poor insulin receptor response even though production ofinsulin is adequate. Hereto it is likely that trans fat deposits,without adaptable trans fat enzymes, and again with 40 to 50 degreesmelting point higher than body temperature may be amenable todisbursement of the fat with low HLB surfactant followed by furtherfluidizing the fat with the high HLB surfactant.

Protein, when misfolded, loses its biologic function in diseases such asAlzheimer's disease, Huntington's disease, and Mad Cow disease withresulting neuropathologic response of tangles, which also may be seenwith lead poisoning and metals such as aluminum and zinc that are underconsideration for their involvement with Alzheimer's disease.

The extracellular matrix material of Component #3 can include, inaddition to collagen and elastin, cartilage derived from tracheal rings(of bovine or shark origin) and complex aggregates of very largemacromolecule straight chain amino polysaccharide hyaluronic acidpolymers of glucosamine and glucuronic acid covalently linked to(proteins and core proteins) and non-covalently linked to chondroitinsulfate.

The function of these extracellular matrix compounds includearchitectural integrity, imbibing of water as a biocolloid, serving as alubricated surface (as exemplified by the synovial membranes (andrationale for a therapeutic application in regard to arthritis) andmaintenance of viscosity analog to component number two the polarsurface active lipids such as but not limited to phosphatidylcholinewith an HLB of 10 to 11. Hyaluronidase has been looked upon in the bodyand therapeutically as a fluidizing, viscosity reducing, thinning enzymewith analog effect of high HLB (15 to 20) surfactants (such as but notlimited to Tween 80 and sodium lauryl sulfate).

A 48 percent inhibition of calcium oxalate urinary tract stone formationwas observed in a multi-center study of more than 120 patients givenglycoaminoglycans sulfated polysaccharide. The remaining patients formedstones that were smaller and more readily removable in regard to crystalcell adhesion. Similar effects with ECM on blood rheology was noted aswith extreme of HLB response with reduction of blood viscosity andlipids as well as anti-coagulant effects.

In other multi-center studies more than 100 patients showed significantimprovement in wound healing with a 48% increase in tensile strength ofhealed wound. Similar effects were noted in controlled animal studies.

Optional components for the compositions of the subject invention,include, but are not limited to, non-hydrolysate-derived milksubstitutes (free of catabolic products and D amino acids such asmicroorganism, derived sources). When used in patients with clinicallysuspected milk allergy or bronchial asthma respiratory tract allergy(such as nasal allergy and hay fever (documentation with allergy skintesting is usually nonproductive)), the patients respond to thistherapeutic composition, which may in terms of therapeutic rationale andmechanism response, most probably reside in the anti-inflammatoryaction, immune modulatory effects completely free of side effects suchas commonly seen soporific effects of the antihistamines used forallergic rhinitis, or the side effects of antiasthmatic sympathomimeticsand corticosteroids. Also as stressed when used in conjunction withthese anti-asthmatic, anti-allergic medications side effects are greatlyminimized. This is exemplified by the avoidance of common soporific sideeffects seen with antihistaminics. As with all these therapeuticapplications, their co-use with medications lessens the dosage and theassociated side effects.

Catabolic products are avoided or absent from the compositions,especially chiral amino acids and racemic mixtures containing aminoacids in D form, as well as, e.g., cyclosporin oligopeptides andbacterial cellular walls. More severe complications of allergic andhypersensitivity diseases may include autoimmune disease such as lupuserythematosis and medication reaction induced false lupus. False lupushas responded to these therapeutic compositions including the collagenproteoglycan aggregate cartilage, chondroitin sulfate complex, therebyavoiding the risks of cortico-steroids, commonly required in thesepatients, particularly in those patients with the complication ofpericardial infusion.

The compositions can also optionally incorporate material that includesstem cells or materials derived from after-birth tissue such as placentaand umbilical cord. The compositions can also include materials thatcorrespond in amino acid composition to mother's milk or to othermaterials encountered during fetal and infantile development.

The compositions of the invention also mimic mother's milk or embryonaltissue. This embryonal tissue simultaneously mimics healing tissue,associated with such diseases as inflammation and tissue damage such astrauma, at the same time mimicking and being analogous to mammalian andparticularly the human stem cell.

In addition, vitamin D supplied in this therapeutic stem cell subjectcomposition and the case in toxic heavy metals would drive and sequesterthese heavy metals such as not limited to lead into the bones by theirchelating; effects thereby greatly minimizing their neurologic to toxiceffects.

Additionally, vitamin D can optionally be added to further direct thisenzyme therapy to the bone marrow involved in lysosomal storage diseaseencroachment on the bone marrow. If therapeutic replacement enzymes arenot available, high HLB surfactant such as but not limited to Tween 80or sodium lauryl sulfate 0.125% to 1% or 10% to 50% of the LD 50 innormal animals with normal HLBs.

In this therapeutic composition can further comprise phosphatidylcholine(PC), commonly derived from the soybean plant by degumming followed byacetone extraction. The highest concentrations of PC are present atbirth during youth and young adult phases of life and then decreasesprogressively until old age. Premature infants are particularly prone toatelectasis or lung collapse, respiratory distress syndrome of thenewborn and may be contrasted with full term infants that have adequatePC levels. The sudden rise in saturated PC at 34 to 36 weeks ofgestation marks the development of fetal lung maturity. Thephospholipids produced represent most of the lipid produced the majorityof which is lecithin-saturated PC up to 85 percent of the lecithin, 60percent of the lecithin is dipalmitoyl PC. Other lipids present arephosphatidylglycerol (PG), phosphatidylinositol (PI),phosphatidylethanolamine (PE).

Plant hormones, such as but not limited to, ethylene, abscisic acid(ABA), and gibberelic acid (GA3), a gibberelin, zeatin a (cytokine),auxins (indole-3 acetic acid, IAA) involved in chemiosmotic protongradients, Zeatin (a cytokine) may be offered in the subjectcompositions for the prevention or reduction of premature births. Theplant hormones may be added to highly hydrophilic surfactants in themodulation of mitosis adding to the management of cancer, and may beincorporated in therapeutic stem cell-like subject compositions, allwith a high degree of bio-safety. This is also emphasized relating toother embodiments concerning modulation of mitosis.

Variants of Tween 80, a highly ethoxylated high HLB hydrophilicsurfactant with 20 moles of ethylene oxide, can be ethoxylated furtherwith 20-40 or more moles of ethylene oxide to increase the HLB.Obversely Myrj represents a low HLB surfactant with 8 moles of ethyleneoxide moles to 1 mole of fatty acid such as stearic acid. Two carbonethylene, (and multiplicity of ethylene oxide derived surfactants),function as a maturation factor, and may be combined with hydrophilicsurfactant activity in these ethoxylated surfactants.

The compositions can be employed for local and systemic therapies andcan be delivered by topical, oral, parenteral or intravenous routes. Inthe case of cancer, intralesional or even intra-arteriallyadministration may be practiced. A more preferred route is oraladministration, preferably by oral mucosal delivery in which thecompositions are formulated into a lozenge or gum that is brought intocontact with the oral buccal sublingual, or pharyngeal mucosal surfacefor a few to twenty minutes (or longer) until absorbed. The high HLBmediated oral mucosal delivery system is as efficacious as parenteraladministration of such medications and prophylactic agents as vaccines(further documented by laboratory measured response in otherembodiments). When an oral route of administration is used, thecomponent concentrations can be lower than in intravenous routes, sincethe components do not pass through the liver. This oral mucosal deliverysystem can also be advantageously used with enzymes or hormonesadministration. The therapeutic compositions are preferably administeredat a temperature slightly less than 100 degrees F., more preferably ator about 98.6 degrees F., to further enhance the synergism of,surfactant and enzymatic activity.

The compositions offer protective effect including but not limited tothe chelating protective elect of the macromolecules such as, but notlimited to, DNA and their protection from toxic chemicals such as heavymetals as well as antioxidant protection from radiation. The exemplaryantioxidants for optional addition to the subject compositions include,but are not limited to vitamin A in the form of beta-carotene, 10,000units per day; D-alpha tocopherol 400 units ideally chelated 200micrograms of selenium to the methionine per day; and/or ascorbic acidpreferably in capsule form 500 milligrams to 8 g (particularly when uricacid levels are elevated and functioning as a natural antioxidant), individed dosages. The effects of the compositions can be long-lasting,with benefits extending for six months or more after therapy isdiscontinued.

The pharmacodynamic basis for successful unexpected therapeutic resultswith the compositions of the invention include (a) hydrogen bonding, (b)anionic charge, (c) electrostatic polar forces, (d) van der Waal forces,and (e) zeta potential associated with the non-covalent interactionswith the macromolecules.

In addition to having anti-inflammatory and tissue healing activities,the compositions provide a biochemical environment in accord with thelaw of mass action that can activate inactive genomic components andincrease expression of one-third or more of the genome therebypotentially countering disease including hereditary conditions. This cancounter a genetic imbalance and can therefore overwhelmdisease-producing genes, even those produced by hereditary changes.

In addition the pharmacodynamic basis for the effects of genetic therapynon-chiral function in a self-perpetuating mode through the Ltetrahedral 3D fit of L-amino acids and glycine non-covalent biochemicalmacromolecular binding to D polysaccharides such-as but not limited tothe genetic system macromolecules DNA, RNA, ribosomal RNA and ribosomesand their respective polymerases furthered by the law of mass actionmediated by progressive :therapy with synthetic therapeutic stemcell-like subject composition of L-amino acid and glycine. Thereby, inaddition, these pharmacodynamic effects of genetic therapy function in aself-perpetuating mode through the biochemical law of mass actionmediated by progressive therapy with synthetic therapeutic tissue andstem cell-like subject composition of L-amino acid and glycine, polarsurface-active lipids and optional inclusion of extracellular matrixscaffold.

L-tetrahedral fit; Surfaces and Tetrahedral fit of each alpha aminoacid. Surface magnification of molar ration (protein) and reactivemoieties and tetrahedral fit in protein synthesis and as therapeuticanti-inflammatory healing therapy,

The C2 through C6 twenty L amino acids and non chiral glycine includingthe 8 C3 propionic acid derivatives are analog to such C3 propionic acidderivative, and Ca4 3butyric acid derivative, anti-inflammatorymedications and their reactive moieties. In contrast the routineanti-inflammatories listed in the PDR are benzene ring containingcompounds from which many medications. and anti-inflammatory drugs arederived, lacking the L alpha amino acid and glycine 3D tetrahedron fitin protein synthesis, actually interfere with protein synthesis, (anon-tetrahedral 3D planar gliding action is present in anti-inflammatorymedication).

The compositions can also be employed for metabolic diseases andconditions such as Type 1 with insulin deficiency wherein the molarratio of the protein insulin may be incorporated into subjectcomposition to stimulate the production of insulin as well as replacingsuspected trace element deficiency such as but not limited to chromiumor type II diabetes and the diabetic state where there is adequateinsulin but with inadequate insulin receptor response which may bemodified with high HLB therapy.

The therapeutic compositions may also be specifically applied toaddiction by mimicking normal tissue metabolism and normal tissueincluding the L-amino acid glycine molar ratio of endorphin tometabolically stimulate and in fact coerce the body to produce thishormone. These same principles and therapeutic components have beenapplied in normalizing, as noted in a prior embodiment's dependency orwithdrawal symptoms such as, but not limited to, the use of drugs incontrolled substances, alcohol and/or drug and tobacco addiction in themedical patient or veterinary practice or experimental conditions suchas the animal or tissue culture. Therefore these compositions form aclinical bridge beyond other advanced technologies that have not to datefound a clinical application. Examples of suitable therapeutic usesinclude the treatment of Crohn's Disease, and in particular PediatricCrohn's Disease (PCD), a chronic, relapsing, unremitting disease withgrave, guarded prognosis for which conventional treatment includeshigh-risk immune suppressants such as corticosteroids at high doses. Inmany cases, particularly in pediatric cases, major surgical interventionis required within five (5) years of initiation of observation, withresection of up to several hundred grams of diseased organ tissue.Surgical intervention effectively arrests disease complications but hasno effect on the clinical course of the disease. In fact, many patientsrequire repeated surgical intervention. The use of these therapeuticstem cell-like subject compositions reduces or eliminates long-termcorticosteroid use in these patients along with reducing side effectsincluding but not limited to the interference and prevention of healing(so important in the management of Crohn's disease or Pediatric Crohn'sdisease) un these patients.

When these tissue normalizing principles and therapeutic subjectcompositions have been used in allergic asthmatic disease, therapeuticbenefits have included: minimizing emergency use of corticosteroids, orpossibly excluding the need for bronchodilator medication effect ofsympathomimetic medication such as the beta sympathomimetic agonists.Further minimizing emergency use of sympathomimetic medications andtheir vicious cycle, of rhinitis medicamodosa or asthmatic bronchitis orpotential bronchopulmonary equivalent asthmatic medicamentosa sideeffects seen with the past inhalation overuse of isoproterenol as thelocked lung syndrome).

Additionally, transplantation or other surgery can be averted incongenital biliary atresia (CBA), a disease that is usually fatal ifleft untreated surgically. Even though CBA has an incidence of 300 casesoccur annually in the U.S. this disease represents the most commonrational for liver transplantation in the pediatric age group.

The co-use of subject composition with the many medications availableand prescribed from the PDR extend synergistic pharmacodynamics of thesesubject compositions and may be integrated with the successfulbio-efficacy of the therapeutic effects of the compositions, exemplifiedby:

(1) reinstitution of organ and tissue function regardless of organ andtissue involved and regardless of etiology, such as but not limited totrauma;

(2) diseases of inherited predisposition such as, but not limited to,lysosomal storage diseases and deficiency diseases such as but notlimited to enzymatic deficiency including for example, lysosomal storagedisease in addition to specific enzyme deficiency replacement, residualtissue and organ dysfunction due to encroachment of distended lysosomesmay be further treated with these subject compositions. This includesHLB modulation with the added advantage of the polar surface activelipid surfactant high HLB packing parameter to synergize, facilitate andaccelerate small amounts of enzyme that may be present. This isaccomplished by increasing surface area, not only of the deficientenzyme, but also of its substrate to maximize the enzyme's metabolicactivity. By these methods, the genetic profile and pattern predisposingto disease in treatment will be minimized and normal genetic functionbecome more dominant. Include as exemplified here but not limited toeven the recessive lysosomal storage diseases.

Diseases and the syndrome of diseases may be viewed here as being analogto an insoluble crystalline ‘thorn in the side’ of the patient's tissueand metabolic processes whether diseases such as obesity with insolublefat particles, atherosclerosis with cholesterol crystals, cancer,genetic diseases lacking enzymes to fluidize and hydrophilize theselysosomal deposits, or other insoluble crystal like structures such asasbestos or silicosis. The liquid crystals provided in this discoverycharacteristic of the polar surface active lipids thereby reverses thesedisease mechanisms structures and functions whether by the highlyhydrophilic polar surface active lipid surfactant and or by the initialin component dispersed at other fat bite highly lipophilic polar surfaceactive lipid surfactant.

The added advantage offered by these surfactants is that by making thesecrystalline or crystalline like non-soluble metabolites randomlydisbursed thereby changing entropy, energy is also provided at the sametime equivalent to energy of metabolizing and fat such as palmitic acidor the combustion of paper with the release of energy to complete themetabolism of these disease causing crystalline structures.

Current medication in the public domain emphasizes the use of (asexemplified in cancer) of platinum and cis-platinum and other alliedanti-cancer therapeutic agents. These agents were originally noted to belethal to infectious microorganisms and this concept and was furthertranslated to the therapy of cancer.

Singular and novel to the prior art is therapy for infectious disease orfor cancer that is not dependent on its lethality to tissue and itsassociated disease but is dependent upon the principle that human tissuecan be facilitated and synergized to assume the function and structureof replicating itself, thereby replacing the vicious cycle of disease.This averts major side effects difficult to accept that are associatedwith therapeutic lethality concept, thereby normalizing human tissueusing compositions that mimic and are analog to human tissue not only instructure but also in function.

Such compositions can be used to treat neoplasms as in cancer orinfectious diseases, in overcoming antibiotic sensitivity, orinactivation without damaging or killing human tissue. In the case ofinfectious disease, the same high HLB polar surface active lipidsurfactant composition as in the anti-cancer therapeutic components asin #2 (which may be used alone or in concert with synthetic stem cellcontaining and compositions #1, 2, and 3) are used to counter suchmicroorganism invasive modalities as lipid A, LPS (lipo-polysaccharideas in toxic shock syndrome) that were formerly antibiotic resistant. Asimilar dual mechanism as with platinum however without major sideeffect concerns.

In inflammation and degenerative diseases without giving up imperativeprotein synthesis in healing associated with the existinganti-inflammatory drugs, synthetic therapeutic stem cell containingcompositions #1, #2, and #3 can be used.

Congenital and genetic diseases can be treated using a composition of a“synthetic stem cell” containing therapeutic compositions #1, #2, and #3without assuming life threatening entree through the portal vein andinfectious microorganism carrier agents. For example, oral mucosaladministration can be used, (thereby bypassing portal vein delivery) inthese so targeted applications.

Trauma management can be performed with the local and systemic use of asynthetic stem cell composition containing compositions #1, #2 and #3,while greatly minimizing additional trauma and salvaging tissue byminimizing the requirement of debriedment. This provides a suturelesswound closure using progressive approximations with steri strips andinactivation of collagenase which has been activated bycortico-steroids, (which has become more commonly used in the managementof chronic diseases)

These foregoing treatments combined as one therapeutic unit butadministered as a single dosage or two to 4 times daily divided dosagesmay be given locally, systemically including intravenous administrationand oral mucosal delivery system companion to this series of inventions.

SUMMARY OF THE INVENTION

Compositions of the subject invention can comprise three, four, or fiveof the following components:

Component #1: 10 to 25 grams of molar ratio amino acids such as but notlimited to Neocate (SHS, Liverpool, U.K.).

Furthered by the law of mass action coercing the protein assemblagesystem three to four times a day, L amino acids and glycinenon-covalently bond and fit with the dextro-rotary pentosemacromolecules of the protein assemblage system's template DNA and RNAthose messenger and transfer RNA and ribosomal macromolecules.

Component #2: Polar surface active lipid, Phosphatidylcholine (PC) 0.9 gadministered one to three times daily, (American Lecithin, Oxford,Conn.) or available in component #1 in L Neocate; Phosphatidylserine(PS) 100 mg contained in a 500 mg complex capsule administered 1 to 3times daily, (Serinaid, Springfield, Utah); anti-inflammatory Omega 3fatty acids, 1000 mg per 2 capsules, 2 capsules two to three timesdaily; 100 mg D-alpha tocopherol antioxidant, antirancidity fish oilcomplex, with active ingredients 180 mg EPA,125 mg DHA and/or seed oilflaxseed oil (250 mg, organically grown replacing 100 mg of DHA). HighHLB polar surface active lipid surfactants such as Tween 80, may be usedalone or with Components #1, #2, and #3 for: (a) modulation of mitosis(>normal), as a normal progression; or (b) normalizing mitosis ofcancer.

In cancer with the therapeutic use of highly hydrophilic surfactant suchas Tween 80 with its hexagonal geometric format microscopically analogto normal mitosis, as shown in other embodiments may now be used tofluidize and normalize to the normal metaphase and anaphase stages ofmitosis to progress to 2 normal daughter cells instead of being arrestedor ‘stuck’, in an analog fashion as an old phonographic record might bestuck at the mitosis organization center MOTC at which site andtransitional time a crystallization like seeding in the growth ofcrystals effect occurs with regard to the tread milling polymerizationof tubulin and microtubulin with new tubulin molecules added at thegrowing advancing end of the microtubules whereas others are lost indepolymerization at the opposite microtubulin end (at anaphasedepolymerization at this end of the microtubules occurs) until theanalog player needle is advanced or normalized as in the case in cancerwith high HLB surfactants. This high HLB anticancer activity has beenshown in foregoing and in prior embodiments.

This normal function of normal progression of mitosis may be furtherenvisioned as clasped hands which progressively separate at metaphaseand the fingers of the clasp hands completely separate and endow eachdaughter cell with the equal quantitative and qualitative complement ofDNA to continue their genetic activity. A maturation factor is alsocontained in the same Tween 80 molecule in the form of ethylene oxide(20 moles), resulting in normal progression resulting in apoptosisfollowed by new cellular regeneration. The hydrophilicity is furtherincreased not only by the 20 oxygen atoms as OH2 in the 20 moles ofethylene oxide and six atoms of oxygen in the one mole of sorbitol butalso by the central double-bond of one mole of oleic acid interruptingthe 17 consecutive CH2 found in the more hydrophobic stearic acid as ananalog “elbow” joint (c) Reduction in abnormal mitosis and cancer cells,approximately 50% histopathologically, after Tween 80, 0.125% ofexposure after 24-48 hours, as well as 76 to 83% cancer cellinactivation in vitro breast cancer tissue culture monitored byinactivation of cancer cell mitochondria, (d) progression of cellularmaturation resulting in apoptosis with ethylene oxide, a maturation andripening factor for fruit in agriculture (an analog structural functionin cell physiology not taught in the prior art), a monomer of Tween 80which contains 20 moles of ethylene oxide.

All of the surfactants may be used as the equivalent weight volumedosage as the 0.125 percent dosage in these embodiments. Or may be usedwith a therapeutic dosage of 10 to 20 to 50% of the LD 50, for exampleTween 80 (with a dosage of 20 to 50% of the LD 50) LD 50 in theexperimental animals (rats and mice) is 7.5 ml per kilogram (identicalto highly lipophilic surfactant PGPR) with a Tween 80 or PGPR dosage of10 to 50% of the LD 50, in a 70 kilogram patient the starting dosagetotal daily dosage would be 50 to 100 ml, further divided into three tofour dosages daily. It must be noted that the LD 50 is based uponstudies in normal animals with normal hydrophilic/lipophilic equilibriumbalance HLB. This specialized use is for patients with abnormal HLBrequiring significant hydrophilic surfactant dosage. Therefore thislatitude expanding the dosage in these patients is therapeutic incontrast to the LD 50 studies of normal HLB animals that did not requireHLB modulation. The LD 50 for sodium lauryl sulfate 1288 mg per kilogramin the experimental animal, (rats orally) with or 900 to 1800 mg,further divided into three to four dosages daily Tween 80. Low HLB polarsurface active lipid lipophilic surfactant PGPR polyglycerolpolyricinolate 0.3% mother range of 0.01 to 0.05% to 10% may be used inany of these applications as a thrust mechanism to disperse and mobilizethe hydrophobic tissue components fat 4 to 12 hours before use offoregoing of high HLB surfactant.

Antioxidants such as D-alpha tocopherol 400 units, ascorbic acid500-1000 milligrams spansule, beta-carotene 10,000 units, along with theL amino acid glycine of this therapeutic composition giving non-covalentDNA macromolecular protection also helpful in this anti-cancertherapeutic application of subject composition.

Component #3: The extracellular matrix can be given in the form of 740mg capsules, 4 to 6 capsules 3 times daily. The capsules comprise aproteoglycan aggregate complex of cartilage, chondroitin sulfatecovalently bonded to core proteins, further non-covalently linked tomacro molecule of hyaluronic acid and collagen (see for example,Cartilade, BioTherapies, Inc., Fairfield, N.J.). Component #3 istherapeutically used along with component #2 self-vesiculatingphosphatidylcholine with HLB of 10 to 11 and will further protect thecell and tissue.

This therapeutic formulation will further protect from radiation damageas in radiation therapy of cancer and/or radiation in regard tobio-terrorism attacks and nuclear plant accidents and in this protectivefunction joins component #1 in radioprotection. Observations regardingamino acid amino groups and SH groups of cysteine should not exceed 1 gper day, however in the case of cancer, larger dosages to be consideredsuch as 1 to 2 grams daily, indicate that the SH group is furtherprotected by other phosphate groups as in phosphatidylcholine ofcomponent #2, or by the addition of adenosine diphosphate with theeffect of promoting differentiation so important in countering the mostaggressive anaplastic aspects of cancer. CSF cytostatic factor may alsobe added synergistically to compositions for this anti-cancer therapy.This may be derived from the cytoplasmic sap of the unfertilized egg andhas similar differentiation promotion factors that are anti-cancer. Thisunfertilized egg CSF cytostatic, cytoplasmic factor may be sourced andderived from any unfertilized ovum including fish eggs, includingsourcing as low allergenic risk potential frogs and/or ostrich eggssince derived from a source where exposure and sensitization has not (oronly rarely) occurred.

The compositions offer protective effects including but not limited tothe chelating protective effect for macromolecules including but notlimited to DNA and their protection from toxic chemicals such as heavymetals as well as antioxidant protection from radiation. The optionaladdition of antioxidants, such as but not limited to vitamin A (in theform of beta-carotene 10,000 units per day) D-alpha tocopherol, 400units, ideally chelated to 200 micrograms of selenium to the methionine,per day, ascorbic acid preferably in capsule form 500 milligrams to 8 gin divided dosages is also contemplated by the subject invention.

The inter-biochemical radio-protection of these components of syntheticstem cell therapeutic composition is analog to the protection ofaminophostine without the very sickening side effects of nausea andvomiting of aminophostine which may be further minimized (as the case inoptional co-use with any therapy with major side effects)1 by thissynthetic stem cell therapeutic subject composition when these three #1components and specific dosages of subject composition are used.

Further to the use of the extra cellular matrix component #3 for themanagement of cancer the addition of ECM component #3 helps to (1)complete the copy of human tissue; (2) it also adds 50% additionalhealing capacity to a wound or disease; and (3) it is of great value incorrecting the healing deficiency of many patients requiringcorticosteroid therapy.

An anabolic medicament is also provided which is involved in tissuehealing and tissue regenerative which along with mimicking the molarratio of the 20 free non D-amino acids specified in the genetic code ofhuman tissue protein. The composition also mimics all the otheressential components of human tissue including the polar surface activelipid phospholipids, such as phosphatidylcholine, omega-3 fatty acidessential fats, as well as the extracellular matrix compositioncomprising: (1) fibrous structural proteins such as collagen andelastin, (2) adhesive glycoproteins such as laminin and fibronectin, and(3) proteoglycans and hyaluronan consisting of a core protein andpolymers of aminated disaccharides which are also sulfatedpolysaccharides and glycosylated proteins (glycoproteins).

The sulfated polysaccharides include, but not limited to chondroitinsulfate and proteoglycan complexes of cartilage wherein chondroitinsulfate are covalently linked to extended core protein molecules whichin turn are non-covalently linked to a huge hyaluronic acidpolysaccharide glycosaminoglycans polymer molecules with the aid of linkproteins. The subject compositions also provide a therapeutic correctionof the major complicating multiple metabolic component deficiencies tosynergistically continue the therapeutic correction of diseases such asCrohn's disease and pediatric Crohn's disease and specific in themanagement of regional ileitis characterizing Crohn's disease in thatthe ileum is normally the sole site of vitamin B 12 absorption anduniquely here whose vitamin B 12 levels are less than ten percent ofnormal: of statistical significance joining a less than ten percent ofnormal vitamin A level (retinol) correction of which locally andsystemically corrects healing deficiency in this disease associated withlong-term steroids along with a less than ten percent vitamin D level,vitamin D, E (D-alpha tocopherol) and prothrombin time in contrast toless than 20% of normal levels of red cell folate, copper, less than 30%zinc, serum folate, plasma ascorbate, less than 50% plasma selenium andhemoglobin other trace elements and minerals and vitamins and enzymestudy such as less than 90% serum and plasma glutathione peroxidase,ferritin of a total of 15 studied components) due to the ravages ofdisease (such as but not limited to progressive severe gastrointestinaldisease such as the chronic granulomatous inflammatory disease such asCrohn's disease which specifically in its pathogenesis targets the ileumand its associated negative nitrogen balance (primary to the disease perse and secondary to malabsorption and enzymatic deficiency and chronicrecurrent severe diarrhea)) and even further complications which includetherapeutic side effects such as but not limited to the side effects ofcortico steroids which include growth retardation and interference withpubertal development.

Inclusive in this response of 450 patients collated as a multi-centerstudy is in response to foregoing therapy and is further inclusive of aresponse to vitamin, mineral, and trace element replacement therapy. Itmay be looked upon therapeutically as mimicking these normal componentsand quantitative levels of vitamins and minerals and trace elements ofhuman tissue.

Each disease group will be studied for deficiencies which will becorrected as exemplified by components #4 and #5 to complete themimicking and analog structure of normal tissue in the normalreplication of human tissue, normalizing its structure and function inorder to bring about the arrest of the vicious cycle of diseases andtheir pathogenic mechanisms.

Component #4: The 4th component in helping to complete and attainmimicking and analog to normal human tissue comprises vitamins,minerals, and trace elements. Utilizing documented deficiencies ofvitamins, minerals and trace elements from available studies orperforming pilot study guide lines. Exemplary deficiencies in Crohn'sdisease are documented in the examples presented. Vitamins, minerals andtrace elements can be provided in various concentrations. For example,vitamin B12 (100 micrograms), vitamin A (as beta-carotene 10,000 units),vitamin D, vitamin E, D-alpha tocopherol, Selenium 200 microgramschelated with methionine as sodium selenomethionine (or to sulfurcontaining cysteine),

Component #5 comprises Phytozyme, (Life Plus Int'l, Batesville Ark.),Amylase 50 mg., Bile 45 mg., Bromelain 30 mg., Lipase 25 mg., Pancreatin6X (NF.) 100 mg., Pancrelipase 110 mg., Papain 30 mg., Pepsin 70 mg.,Betaine HCl 100 mg., and Probiolic Blend 20 mg tablet.

Ingredients: Betaine, HCl, Pancrelipase, Pancreatin 6X (N.F.), Pepsin,Dicalcium Phosphate, Amylase, Bile, Bromelain, Papain, Lipase,L-Glutamic Acid, (ProBio Tex.), Stabilized Probiotic Blend (Each dosage:200,000,000 pro-biotic micro-flora including Lactobacillus acidophilusDDS-1, Bifido-bacterium bifidum, Lactobacillus bulgaricus, Lactobacillussalivarius), vegetable and fruit concentrates. Deficiencies ofpancreatic enzymes are readily available in exampled disease, Crohn'sdisease, along with cystic fibrosis. Therefore corrected here in thetherapeutic component formulations to normalize not only human tissuebut its secretions. Reversal to normal flora with pro-biotic alsoreadily available and, therefore, used here for the same therapeuticrationale of normalization of tissue, its symbiotic surface bacteria andassociated secretion contents of enzymes.

This detailed therapeutic replication of normal human tissue secretions,deficient in such diseases as Crohn's disease and cystic fibrosis, (andtherefore synergizes further complete reversal of disease tissue). Byincluding therapeutic components #4 and #5 and secretions of the tissueand the normalization of the micro-organism flora with associatednormalization of function of this gastrointestinal Crohn's diseasedtissue has made possible for this patient for the first time to furtherreduce from one tablet of the corticosteroid that this three componenttherapy has permitted to use ½ tablet instead (Triamcinalone, generic)for the first time in three decades. The side effects this patient hassustained from long-term corticosteroids has been worsening ofosteoporosis documented by two successive bone scans two years apart,recurrent bruising and failure to heal including two threats of the needfor skin graft which this subject composition stem cell-like treatmenthas prevented.

Component #5: In the case of the gastrointestinal tract in diseases suchas, but not limited to, Crohn's disease, the addition of enzymatictherapy of composition #5 and the addition of pancreatic and enzymaticreplacement of deficiencies present herein normalizes thegastrointestinal secretion component and byproduct of human tissue. Theaddition of pro-biotic microorganism therapy such as, but not limitedto, Saccharomyces Boulardii helps normalize the abnormal microflora thatthe disease gastrointestinal tract such as but not limited to Crohn'sdisease predisposes to thereby even further normalizing abnormalmicroflora (which this vicious cycle chronic granulomatous Crohn'sdisease has fostered) the gastrointestinal microflora, tissues andsecretions.

An extension of treatment of the synthetic stem cell therapy subjectcomposition in the same patient as Ex. 1 with the addition of component# 4 presented in detail in Ser. No. 09/639, 859 and Therapeuticcomponent # 5 enzyme and pro-biotic 0.9 g tablets two tablets daily tothree times a day preferably before meals of enzyme replacement andpro-biotic microflora normalizing factor. These favorable conditionsmake it more and more difficult for the diseased tissue, such as but notlimited to chronic granulomatous disease, as in Crohn's disease andthereby reversing the vicious cycle of this disease and other diseasessuch as but not limited to Crohn's disease. This has proved itselfclinically in the embodiment example cited here wherein digestive enzymeformulation containing pancreatic enzyme replacement, (as well as bilewhich has also been incriminated as deficient in Crohn's disease) alongwith pro-biotic micro-organism resulted in flora normalization. Thepro-biotic in this case was Lactobacillus acidophilus, Bifidobacteriumbifidum, Lactobacillus bulgaricus, Lactobacillus salivarius use of inthis addition and completion of the normalization therapeutic stemcell-like repair kit formulation.

Most importantly component steps are analogous to a team or corporateapproach to the anabolic reconstructive reversal of the pathogenesis ofa complex vicious cycled catabolic destructive disease further analog tothe underlying pathogenetic mechanisms and the basis of the formerrefractory state of disease. Crohn's disease and many other diseaseswith such analogous pathogenetic destructive componential mechanisms,associated deficiencies and medication side effects can be treated withthe subject composition. Preferably to best address this disease state,all components of synthetic stem cell like subject compositionformulations are contained in the molar ratios of human tissue.

The human tissue normal molar ratios of these foregoing componentsinclude such as, but not limited to, non D-amino acids of the 20 aminoacids specified in the human genetic code, polar surface active lipidssuch as, but not limited to, cell membrane components, extracellularmatrix components, vitamins, minerals, trace elements are herein definedas being at least 90% of the composition by weight and 10% by weight orless of composition that is not in conformance with the molar ratios byweight of human tissue. Preferably the human tissue molar ratio ofcomposition of these components are at least 95 percent by weight andfive percent by weight or less not strictly corresponding to the molarratio of human tissue, and most preferably the human tissue molar ratiocomponent composition corresponding to over 99% by weight and 1% or lessnot strictly corresponding to the molar ratio of human tissue.

The prior embodiments documented such as but not limited to the reversalof the need for skin graft in wound treatment of a Crohn's patient(exemplified by adding deficient vitamin A locally to anabolic countercollagenase stimulated by long-term corticosteroids along with woundhealing anabolic zinc in the form of zinc oxide in the local andsystemic anabolic therapy using locally and systemically subject toposition synthetic stem cell-like medicament. Resulting in mechanismsalso associated with the successful reduction in the need for long-termcorticosteroid observer, in 85 percent of the 450 patients studied.

The subject composition also provided for a marked reduction in thenecessity for major abdominal surgery (excisional bowel surgery andcorrection of fistulization is required in 70 percent of pediatricCrohn's disease patients in a period of conventional therapy five yearcare (data provided by the Ileitis Foundation of America) as exemplifiedby a 60 percent reduction in the need for correction of fistula bysurgical care. In the 40 percent remaining that require major abdominalbowel surgery this therapy offers a further 55 percent reduction insurgical mortality.

Pediatric Crohn's disease is a disease of hereditary predispositionhowever it this specific antiinflammatory treatment is discontinuedafter one month of therapy (as might occur in the management childrenconsidering stomach tube administration in the past), the absence ofrecurrence is noted to be as long as six months in those thatdiscontinued treatment (70 percent fortunately do not recur in 7 to 12months of further observation after discontinued treatment). This issuggestive of a genetic therapeutic component associated with thistreatment

The therapeutic application of the subject compositions also provideanti-inflammatory therapeutic responses without the usual associatedcomplication of impairment of tissue protein synthesis and therebyfurther aggravation of negative nitrogen balance.

Documented studies here showed that further correction of thesedeficiencies added to any therapeutic plan added significantly to theprevention of this disease's significant predisposition for recurrences.Also included were enzymatic therapy and essential omega-3 EPA fattyacid fats with their contribution to this anti-inflammatory therapy aswell as the addition of extracellular matrix (ECM), and reversal ofimpaired healing (associated with pediatric Crohn's disease andlong-term steroids).

The addition of these deficiency corrections would further add to themanagement of this formerly intractable vicious progressive chronicgranulomatous disease pediatric Crohn's disease in the growing child.Potentially contributing to the 15% of patients (vs. the 85%) that werenot able to replace corticosteroids.

The components of the subject invention can, in some embodiment, becombined to form compositions. For Example, components #1 and #3 can beuseful for anti-inflammatory or healing. Component #1 can be used to aidin protein formation and component #2 can be used to replace damagedcell membranes. Component #3 increases tensile strength of wound by 48%in more than 100 patients multi-center and double-blind, as well as incontrolled animal studies and component #2, modified PC lysolecithintriggers onset of protein synthesis working synergistically withcomponent #1.

Liquid crystal high HLB surfactants HLB>13 specifically 15-16 to 20 witha high packing parameter of less than ½ and contributing a highrepulsive of charge zeta potential along with an increase in surfacearea and thereby synergize enzymatic activity of enzyme in associationwith a substrate, (thereby synergizing component #5) and as ananti-cancer agent also down modulating mitosis (in vitro documentationin prior embodiments) and especially in the use of Tween 80 containing20 moles (or more) of ethylene oxide a maturation factor highly usefulin the stimulation of apoptosis, a highly useful anti-cancer feature.The anti-cancer therapeutic features may be used alone or in conjunctionwith components 1, 2 and 3 as well as components one, two, three, fourand five.

These subject compositions may be administered orally or parenterally orlocally and in special applications as in anti-cancer may even beadministered intra-arterially as therapy used in conjunction withroutine medications to reduce side effects and synergize these companionmedications and thereby lessen the dose required of routine medications.

In simulating all stem cell biochemical biophysical features simulatedresults as evidenced by averting need for an organ transplant whileavoiding key stem cell side effects:

-   -   (1) Bioethics independent of use of human embryonic tissue, but        can build and rebuild thereby enhancing tissue healing, protein        synthesis on existing tissue and in-vitro recombinant DNA tissue        culture,    -   (2) Avoiding the risk of transmission of such diseases as AIDS        and Hepatitis and even cancer cells (incipient),    -   (3) Avoiding the risk of rejection reaction and the need for HLA        cross matching,    -   (4) Adding a significant anti-tumor anti-cancer effect,    -   (5) Sourcing has avoided the risk of allergic reaction by        avoiding protein or substances that would cross match the        patient's genetic code,    -   (6) May be used freely with other medication to reduce their        significant risk and dosage of medication.

In certain embodiments of the subject invention, a compositioncomprising: a) at least one glycosaminoglycan, proteoglycan aggregatecomplex of hyaluronic acid, extracellular matrix, protein andchondroitin, extracellular matrix compound in an amount effective in thedamaged tissue as an anti-neo-inflammatory and anti-neo-angiogeneticagent; b) about one to three grams of at least one polar surface activelipid selected from the group consisting of phosphatidic acid,phophatidylethanolamine, lecithin, phosphatidylserine,phosphatidylinositol, 2-lysolecithin, plamalogen, choline plasmalogen,phostidylglycerol, diphosphatidylglycerol, sphingomyelin, and anycombination of 2, 3 4 5 6 7 8 9 10 or of said polar active surfacelipids; c) a plurality of enantiomerically pure D-amino acids andglycine of about 9 to 25 grams; d) a component selected from the groupconsisting of polyoxyethylene Sorbitan Monooleate (TWEEN 80), Sorbitanmonooleate, grape seed extract, grape extract, and combinations thereof;and e) vitamins, minerals or trace elements selected from the groupconsisting of Vitamin B 12, Vitamin E, selenium, zinc, and combinationsthereof is provided. Compositions of the subject invention can furthercomprise a compound generally accepted as safe (GRAS) selected from thegroup consisting of aspartame perfluorocarbon resins, perfluorocarboncured elastomers. [alpha]-Amylase enzyme preparation from Bacillusstearothermophilus, benzoic acid, bromelain, catalase (bovine liver),lactic acid, linoleic acid, potassium acid tartrate, propionic acid,stearic acid, tartaric acid, diacetyl tartaric acid esters of mono- anddiglycerides, ammonium bicarbonate, ammonium carbonate, ammoniumchloride, ammonium hydroxide, ammonium citrate, dibasic, ammoniumphosphate, monobasic; ammonium phosphate, dibasic; bacterially-derivedcarbohydrase enzyme preparation; bacterially-derived protease enzymepreparation; bentonite; benzoyl peroxide; n-Butane and iso-butane;Calcium glycerophosphate; Calcium lactate; Calcium pantothenate; Calciumpropionate; Calcium stearate; Carbon dioxide; Beta-carotene; Cellulaseenzyme preparation derived from Trichoderma longibrachiatum; Clove andits derivatives; Cocoa butter substitute; Copper gluconate; Coppersulfate; L-Cysteine; L-Cysteine monohydrochloride; Dextrin; Diacetyl;Enzyme-modified fats; Ethyl alcohol; Ficin; Glucono delta-lactone; Corngluten; Wheat gluten; Glyceryl monooleate; Glyceryl behenate; Glycerylpalmitostearate; Helium; Inositol; Insoluble glucose isomerase enzymepreparations; Isopropyl citrate; Animal lipase; Magnesium carbonate;Magnesium chloride; Magnesium hydroxide; Magnesium oxide; Magnesiumphosphate; Magnesium stearate; Magnesium sulfate; Malt; Malt syrup (maltextract); Manganese chloride; Manganese citrate; Manganese gluconate;Manganese sulfate; Microparticulated protein product; Mono- anddiglycerides; Monosodium phosphate derivatives of mono- anddiglycerides; Niacin; Niacinamide; Nickel; Nitrogen; Nitrous oxide;Peptones; Pancreatin; Papain; Pectins; Pepsin; Potassium bicarbonate;Potassium carbonate; Potassium chloride; Potassium hydroxide; Potassiumlactate; Propane; Pyridoxine hydrochloride; Rennet (animal-derived) andchymosin preparation (fermentation-derived); Riboflavin;Riboflavin-5′-phosphate (sodium); Sodium benzoate; Sodium carbonate;Sodium hydroxide; Sodium hypophosphite; Sodium lactate; Sodiummetasilicate; Sodium propionate; Sodium sesquicarbonate; Sodiumtartrate; Sodium potassium tartrate; Starter distillate; Stearylcitrate; Thiamine hydrochloride; Thiamine mononitrate;[alpha]-Tocopherols; Triacetin; Tributyrin; Triethyl citrate; Trypsin;Urease enzyme preparation from Lactobacillus fermentum; Vitamin A;Vitamin B12; Candelilla wax; Carnauba wax; Bakers yeast extract; Zein;Sulfamic acid; Clay (kaolin); Ferric oxide; Iron oxides; Japan wax; Talloil; Alfalfa; Allspice; Almond, bitter (free from prussic acid);Ambrette; Angelica root; Angelica seed or stem; Angostura; Anise;Asafetida; Balm; Balsam of Peru; Basil; Bay leaves; Bay; Bergamot(bergamot orange); Bois de rose; Cacao; Camomile (chamomile); Capsicum;Caraway; Cardamom seed (cardamon); Carob bean; Carrot; Cascarilla bark;Cassia bark, Chinese; Cassia bark, Padang or Batavia; Cassia bark,Saigon; Celery seed; Cherry, wild, bark; Chervil; Chicory; Cinnamonbark, Ceylon; Cinnamon bark, Chinese; Cinnamon bark, Saigon; Cinnamonleaf, Ceylon; Cinnamon leaf, Chinese; Cinnamon leaf, Saigon; Citronella;Citrus peels; Clary (clary sage); Clove bud; Clove leaf; Clove stem;Clover; Coca ; Coffee; Cola nut; Coriander; Corn silk; Cumin (cummin);Curacao orange peel; Cusparia bark; Dandelion; Dandelion root; Dill; Doggrass (quackgrass, triticum); Elder flowers; Estragole; Estragon(tarragon); Fennel, sweet; Fenugreek; Galanga (galangal); Garlic;Geranium; Geranium, East IndianGeranium, rose; Ginger; Glycyrrhiza;Glycyrrhizin, ammoniated; Grapefruit; Guava; Hickory bark; Horehound(hoarhound); Hops; Horsemint; Hyssop; Immortelle; Jasmine; Juniper(berries); Kola nut; Laurel berries; Laurel leaves; Lavender; Lavender,spike; Lavandin; Lemon; Lemon balm (see balm); Lemon grass; Lemon peel;Licorice; Lime; Linden flowers; Locust beanLupulin; Mace; Malt(extract); Mandarin; Marjoram, sweet; Mate 1; Menthol; Menthyl acetate;Molasses (extract); Mustard; Naringin; Neroli, bigarade; Nutmeg; Onion;Orange, bitter, flowers; Orange, bitter, peel; Orange leaf; Orange,sweet; Orange, sweet, flowers; Orange, sweet, peel; Origanum; Palmarosa;Paprika; Parsley; Pepper, black; Pepper, white; PeppermintPeruvianbalsam; Petitgrain; Petitgrain lemon; Petitgrain mandarin or tangerine;Pimenta; Pimenta leaf; Pipsissewa leaves; Pomegranate; Prickly ash bark;Rose absolute; Rosa; Rose; Rose buds; Rose flowers; Rose fruit (hips);Rose geranium; Rose leaves; Rosemary; Rue; Saffron; Sage; St. John'sbread; Savory, summer; Savory, winter; Schinus molle; Sloe berries;Spearmint; Spike lavender; Tamarind; Tangerine; Tannic acid; Tarragon;Tea; Thyme; Triticum; Tuberose; Turmeric; Vanilla; Violet flowers;Violet leaves; Violet leaves absolute; Wild cherry bark; Ylang-ylang;and; Zedoary bark, or any combination of said compounds. Anycombinations of the compounds GRAS can be used in formulatingcompositions of the subject invention. In some embodiments, thecomposition further comprises a flavorant that can be a fruit juice,such as tomato juice.

The following sections of Title 21 of the Code of Federal Regulationsare hereby incorporated by reference in their entireties (with respectto materials generally recognized as safe (GRAS)): §§5, 25, 170, 172,173, 177, 182, 184, 186, 570, and 582.

EXAMPLES

The following examples are used to illustrate preferred embodiments ofthe invention and are not meant to limit the scope of the invention inany way.

Example 1 Example of Multi-Center Study

Within three to six weeks of initiation of this treatment using thecompositions of the invention, 85% of CD and PCD patients studied indouble-blind, placebo-controlled multi-center including 35radiographically tagged inflammatory neutrophile permeability studies aswell as the open study were able to discontinue the immune suppressiontherapy.

Remarkably, the discontinuance was not associated with relapse for aperiod of at least six months. Seventy percent maintained thedisease-free state for as long as one year. Growth arrest and pubertysuppression were overcome within six weeks in more than 20 patients witha predictable efficacy of over 90% in. 150 patients (⅓ of 450 studied;PCD cases treated exceed 200 patients). Controlled in vitro tissueculture studies of biopsied Crohn's tissue evidenced 'significant 80%reduction in inflammatory mediator chemokines relative to controls after24 hours.

The compositions also avert the need for surgery to address anotherCrohn's Disease complication (intestinal fistulae) in more than 60percent of the cases, and in those cases that require surgery more than50 percent reduction surgical mortality with use of subjectcomposition).

Example 2 Example of CBA

Therapy with the compositions of the invention in one CBA patient usingcomponents #1 and #2 re-established organ function, -stimulated tissuehealing and tissue protein synthesis concurrent with significantanti-inflammatory activity, clearance of all abnormal liver function.Liver ultrasound resulted in cancellation of scheduled liver transplant,averting liver transplant.

Example 3 Crohn's Disease, CaseE Report, Part (A)

A 71 year old female patient with more than 3 decades of Crohn's diseaserecently had a flare up of the Crohn's disease, unsatisfactory responsefrom 4 mg of corticosteroid, once daily then increased to 4 times dailyfor acute flare ups. These flare ups prior to adding stem cell-liketherapeutic three component composition, #1 and #2 in infant Neocate,SHS, L-amino acid glycine analog to mimicking the molar ratio of breastmilk, 10 to 25 grams 2 to three times daily were effective in preventingflare ups and the need for an increase in corticosteroid 4 with itsmultiplicity of serious side effects to 4× daily 1-2 day, 3×d 1-2 day,2×d 1-2 day, 1× daily maintenance dosage. The patient had been receiving5-10 to 25 grams of L-amino acid and glycine, analogue molar ratioaccording to the genetic code to breast milk and lecithin(phospholipid-PC), responded to the addition of the third componentextracellular matrix, collagen, proteo-glycan aggregate complex ofcartilage and chondrotin sulfate (shark cartilage 740 mg. per capsule, 4capsules twice daily). Thereby, analogue to and more completelymimicking human tissue adding stem cell like therapeutic three componentcomposition for an acute flare-up of the acute symptoms of abdominalpain and diarrhea cleared within 24 hours and the improvement continuedthe past few weeks responding to the least amount of corticosteroids(alternating daily dosages of a half a tablet (2 mg) with a full tablet(4 mg), the least corticosteroids required to prevent flare-ups in thepast several decades of management.

This reduction in dosage is mandatory because of the severe unsightlybruising and poor healing of lacerations and associated intolerance ofsutures inducing even further bruising with a mimicking the healing oflacerations even more difficult (a common complication associated withlong-term corticosteroids even if the dosage is only one tablet daily;having refused 6 mercaptopurine offered by her consultinggastroenterologist because of the possible complication of cancer). Herlacerations have been most successfully healed with non suturesteristrips providing successful, and most amenable, addition ofbringing the edges of the laceration in closest approximation because ofthe abnormal retraction of the wound (a difficulty observed in thecorticosteroids treated patients in contrast to normal contraction ofthe wound). A therapeutic measure not noted in the prior art.

Another therapeutic component, comprising 2.1 grams of omega 3 seed oil,(flax oil, sunflower oil, sesame seed oil 1.7 grams of omega 6 oil, and1 gram omega 9 oil (Flora brand), with the following well toleratedpreferred recent substitute of omega 3 fish oil and seed oil (2 capsules1-2 times daily, Thera Tears, serving size 2 softgels per serving,containing per 2 capsule Vitamin E (as D-alpha tocopherol concentrate)100 IU (anti-rancidity antioxidant), Organic Flaxseed Oil 500 mg., EPA(Eicosapentaenoic Acid) (from Fish Oil) 225 mg, and DHA (DocosahexaenoicAcid) (from Fish Oil) 50 mg has also added to components #1 and #2. Theanti-rancidity antioxidant vitamin E present in this capsule preventsthe development of catabolic products that are counter to the componentsof this therapeutic innovation accounting for the tolerance of this fishoil product.

This patient is one of the unusual patients intolerant to the preferredof therapeutic component #2 polar surface active lipid anti-inflammatorycomponent fish oil. Patients with ileitis have a deficiency ofpancreatic lipase and enteric coated fish oil capsules may be morehelpful in overcoming this intolerance. Oral mucosal delivery system ofprior embodiments may also be useful as in prior embodiments and lipasesupplied would be of salivary gland origin. This anti-inflammatoryimmune modulatory pharmacologic activity is furthered by the synergisticanti-oxidant vitamin A 5,000 units, 250 ml. of vitamin C, 400 ml.vitamin E (D-alpha tocopherol) and selenium 20 mg and Zinc 15 mg. Thiseffect can be seen when used locally in this patient as a localapplication of zinc oxide in stimulating healing of skin trauma and whenused to minimize the need for antibiotics, in the treatment of acuterespiratory infections, and to provide similar protective effect priorto dental care in the form of zinc, glycine with optional Echinacea.

It should be noted here that significant progress has been made here andin these foregoing embodiments in masking a major problematic taste ofthe amino acid component which formerly, in the prior art, brought aboutthe requirement of gastric tube administration and associatedhospitalization.

Encapsulation of the medication would eliminate use of the gastric tubeby by-passing the problematic taste of the amino acid component.However, for the pediatric or adult patient who can not take capsules, avegetable flavored juice such as, but not limited to, tomato juice or V8could be used as a flavored vehicle. One heaping teaspoon (approximately5 grams) to 5 ounces of juice, was found by a taste panel to thoroughlymask the most objectionable taste of the first component, the amino acidproduct. This amino acid component includes, but is not limited to,Neocate for Infant use. This Crohn's patient was included in our tastepanel in our attempt to improve the palatability of the objectionableamino acid component of subject composition.

Case report: Example 3, part (b) Crohn's disease

Further response to addition of therapeutic components # 4 and #5 (All 5component therapeutic composition response).

Further progress report and addition of components #4 and #5 to thispatient care added even further to significantly improve her clinicalcourse. The addition of components #4 and #5 have provided fornormalization of enzyme composition secretion of the tissue and thenormalization of the micro-organism flora with associated normalizationof function of this gastrointestinal Crohn's diseased tissue has madepossible for this patient for the first time to further reduce from onetablet of the corticosteroid that this three component therapy haspermitted to use ½ tablet of corticosteroid (triamcinalone generic) forthe first time in three decades without usual further steroid withdrawalsymptoms of arthralgia common in steroid withdrawal as noted repeatedlyin this patient in the past unsuccessful attempts of steroid reduction.

The side effects this patient has sustained from long-termcorticosteroids has been worsening of osteoporosis documented by twosuccessive bone scans two years apart, recurrent bruising and failure toheal including two threats of the need for skin graft which this subjectcomposition stem cell-like treatment has prevented. Bruising and healingtime of skin trauma as well as GI flare ups of diarrhea greatlyimproved.

Example 4 Countering Wound Healing Impairment with Steroids

The prior embodiments documented the reversal of the need for skin graftin wound treatment of a Crohn's patient (exemplified by adding deficientvitamin A locally to anabolic counter collagenase stimulated bylong-term corticosteroids) along with wound healing when zinc, in theform of zinc oxide, was added to composition #5.

Example 5 Orthopedic and Anti-Arthritic Subject Composition Therapy—CaseReport

A female patient age 48 has been treated for acute degenerativearthritis right hip confirmed by x-ray findings. Acute onset, May of 02associated with progressive pain limping and requirement of support witha cane temporarily relieved by anti-inflammatory drug Vioxx with x-rayfindings of severe inflammatory degenerative arthritis associated withabsence of joint space of right hip joint and clinical regression righthip. Joint prosthetic replacement even though only age 48 wasrecommended by rheumatologist and orthopod. Patient refused surgicalcare and responded with use of extracellular matrix:

ECM: Glucosamine 750 mg. daily, Shark cartilage 450 mg., Cartilage 50mg, gelatin, a denatured collagen, porcine origin, 1 to 2 tablespoons infruit juice.

The addition of an anti-inflammatory immune modulator (omega 3 flax-seedoil, 1000 mg) provided a progressive response with reappearance of thehip joint space on x-ray (severe inflammatory changes had interferedwith visualization of any joint space). Since the patient is nowpain-free and no longer requires a cane supportive of walking, howeverstill had a mild limp, the completion of the synthetic stem cell firstand second component chiral L amino acid and non chiral glycine in themolar ratio of human tissue supportive of the stem cell, along withpolar surface active lipid as phospholipid lecithin was suggested in theform of Neocate progressing from 5 grams daily to 15 grams daily tothree times daily. It is expected that this additional therapy shouldsignificantly add to the therapeutic response progression.

Anti-inflammatory, immune modulatory bio-efficacy, biosafety andpharmacologic activity is present with all four components of syntheticstem cell therapeutic subject composition.

Example 6 Inactivation of Cat Dander Allergen of Cat, to LessenRespiratory Allergy Symptomatology After Cat Exposure (with TherapeuticComponent #2)

High HLB liquid crystalline phase semi-conductor bio-computer used hereand its biophysical hydrophilic micellar counterpart with itsanti-allergenic subject composition therapeutic embodiments, in vitrobasophilic de-granulation measure by histamine release comparingefficacy of treated cat dander in preventing histamine release withuntreated cat dander when exposed to serum from cat allergic patients.

Example 7 The Use of High HLB Surfactant in Cancer may be Used Alone oras an Optional Component of Component #2.

Comparative studies of inactivation of in-vitro cancer using tissueculture techniques with high HLB surfactant, Tween 80 are illustrated inTable 1.

Results of Treating T47D breast cancer tissue cells (Normalized):

TABLE 1 MTS (Breast cancer Mitochondrial activity Assay) % normalizationof Breast cancer Culture Time 24 h 48 h cells Control 1.0 1.0  0%**Tween 80 (0.125%) 0.48 0.24 76% PC (0.125%) 0.92 0.98 Tween 80 + PC0.61 0.42 58% (0.125% + 0.12596) GS-1 (grape seed 0.29 0.17 83% Extract,0.5 mg 1-ml Tween 80 + GS-1 0.27 0.17 83% PC + GS-1 0.34 0.17 83% Breastcancer (Comparative histopathologic studies before and after treatmentwith high HLB Tween 80 surfactant **Histopathologic studies correlatewith a more than 50% reduction of cancer cells seen after 48 hours oftreatment with 0.125% Tween 80.

Summary of Cell Inhibition Assays

Development of metastatic cancer involves several steps, usuallyseparated in to initiating and promotional steps. Initiation involvessomatic mutation leading to altered expression of genes controlling DNAsynthesis and cell replication. Promotion involves stimulation of themutated cell to continued division. Subsequent mutations in thesealtered cells lead to more aggressive replication and invasion ofneighboring tissues. In many tumors, the tumor cells are cycling whiletheir neighbors are in the GO phase of the cell cycle. Substances whichinterfere with mutagenesis or with cell division could prove to beanti-carcinogenic.

Several extracts of these for their abilities to inhibit the metabolismof cells isolated from breast and cervical cancer tissue have beenexamined in regard to the anti-cancer effects of extracts which haveproven capable of significantly inhibiting the metabolism of thesecancer tumor cells. In addition to and equal to the effects of high HLBsurfactants for comparative testing. These comparative studies wereperformed and results are reported in the above table. Metabolism wascomparatively measured with controls and other extracts as to thereduction of mitochondrial activity, (MTS). This compound is a substratefor the mitochondrial enzymes—and is reduced to a blue formazan product.

Activity of the extracts was tested with the MCF-7 and T47-D breastcancer cell lines and against the CaSki and SiHa cervical cell lines.During the later experiments, the CRL 7367 and CRL 7368 cell linesbecame available and were included in subsequent trials. CRL 7368 is aline established from transformed fibroblasts isolated from a breastcancer. CRL 7367 was established from apparently healthy skinfibroblasts taken from the same donor.

Methods

In the first experiments—The extracted therapeutic test agents werederived from specified tissue. Water extracts of the crushed tissue,were also prepared. For the later experiments, specific varieties ofextracts were prepared and examined: Cells were obtained from AmericanType Culture Collection (ATCC, Washington, D.C.) and were cultured asrecommended by ATCC. Experiments were performed in 96 well microtiterplates. Each well contained 1.0×10⁴ cells suspended in a total volume of200 ml. Test wells contained the designated amount of extract in cellculture medium. Control wells contained the same amount of extractsolvent in medium. Plates were incubated in an atmosphere of 5% CO₂ for24 or 48 hours with extract or solvent. At this time, -pl-(MTS) wereadded to each well and incubation was continued for an additional 4hours after which time the optical density (OD) at nm of each well wasrecorded. In each experiment, each sample was assayed in triplicate andthe mean optical density (OD) for the three wells containing the sameculture was calculated.

Results

Data are presented as suppression ratios. The suppression ratio definedhere as the mean optical density (OD) for the wells containing extractdivided by the mean optical density (OD) for the control wells. A valueof this ratio of 1.0 indicates that the extract had no effect onmetabolism of the cells being tested. A value of less than 1.0 indicatesinhibition of cell metabolism by the extract or the high HLB surfactantTween 80.

The purpose of the work was to determine which therapeutic agentextracts (further separated by chromatography) explored through thismethodology for anti-cancer activity. The data presented here representssemi-quantitative anti-cancer screening tests. Extracts with ratios inthe range 0.51-0.74 were considered moderately active and thereforeappropriate for considered use along with preventive anti-cancertreatment and active anti-cancer treatment. In co-use with anti-cancertreatment and radiation treatment, may lessen the dose and the sideeffects of these current therapeutic agents. Extracts with metabolismsuppression ratios less than or equal to 0.5 represented a suppressionof metabolism of at least 50% or greater than that of the controls andwere considered definitely active potential anti-cancer agents, as wasthe case of High HLB Tween 80 with ethylene maturation apoptosispromoting factor with a 76% suppression of mitochondrial metabolism ofcancer cells.

In the first experiments, tissue extract prepared in the laboratory andwater extract from tissue commercially obtained were, comparativelyexamined. These results were presented in Table 1. The data indicatedthat comparatively both therapeutic agents derived from tissue extractsfreshly prepared in this laboratory and water extract inhibit can cellmetabolism at the higher concentrations tested. There is a clear doseeffect indicating that therapeutic agents derived from tissue extractsprepared in our laboratory at concentrations lower than 0.004 andcommercially available water extract concentrations lower than 0.02 donot inhibit metabolism. Data for alcohol extracts were also presented.The extracts had minimal effects on metabolism after three days oftreatment, but after five days of treatment the ethanol extract hadinhibited metabolism of both breast cancer cell lines by over 60%. Someextracts suppressed the MCF-7 cell One, but had minimal effect on theT47-T cell line or on the cervical cancer cell lines even when theextract anti-cancer treatment agent composed 4% of the total culturevolume. Of all the extracts examined the tissue extract anti-cancertreatment agent obtained with 70% acetone/30% water was the most active.

-   -   Acetone is an agent used in separating phospholipid surfactants,        e.g. phosphatidylcholine (PC), phosphatidyl serine (PS),        phosphatidyl inositol (PI), and phosphatidyl ethanolamine (PE)        acetone insoluble representing 58% of surfactants present in soy        lecithin. 70% acetone and 30% water used here as a tissue        extracting agent is most probably a hydrophilic surfactant.

Example 8 Case Report—Therapeutic Composition to Counter WithdrawalSymptoms and Side Effects of Medications and Drugs and Drug Addictionand Dependency

The Therapeutic Results and Rationale for inclusion of Components #4 and#5: This detailed therapeutic replication of normal human tissue (andtherefore complete reversal of disease tissue) and by including theproducts of therapeutic components #4 and #5, (added to components #1,#2, and #3 past month and added past two months to care of priorpatient), normalization of enzyme composition secretion of the tissueand the normalization of the micro-organism flora with associatednormalization of function of this gastrointestinal Crohn's diseasedtissue has made possible for this patient for the first time (and notreported or taught in that art) to further reduce from one tablet of thecorticosteroid that this three component therapy has permitted to use ½tablet instead of corticosteroid (triamcinalone, common generic) for thefirst time in three decades without usual further steroid withdrawalsymptoms of arthralgia common in steroid withdrawal as noted repeatedlyin this patient in the past unsuccessful attempts of steroid reduction.

The side effects this patient has sustained from long-termcorticosteroids has been worsening of osteoporosis documented by twosuccessive bone scans to years apart, recurrent bruising and failure toheal including two threats of the need for skin graft which this subjectcomposition stem cell-like treatment has prevented. Bruising and healingtime of skin trauma as well as GI flare ups of diarrhea greatlyimproved.

These therapeutic compositions may also be specifically applied toaddiction by mimicking normal tissue metabolism and normal tissueincluding the L-amino acid glycine molar ratio of endorphin tometabolically stimulate and in fact coerce, by the law of mass action,the proteins assemblage system of the body to produce this hormone.Since one mole of tyrosine, two moles of glycine and one mole ofphenylalanine seem to be essential for the narcotic effects of betaendorphin and the met and leu-enkephalins, this anti-addiction effectthen would be compared to the complete L-amino acid glycine molar ratioof beta endorphin. This molar ratio of beta endorphin also includes onemole of methionine, two moles of threonine, two moles of serine, fourmoles of lysine, two additional moles of phenylalanine, one mole ofglutamine, one mold of proline, one mole of valine, one mole of leucine,two moles of asparagine, two moles of alanine, two moles of isoleucine,one mole of tyrosine, one mole of glycine, and one mole of glutamicacid.

The same principles and therapeutic components have been applied innormalizing, as noted in prior embodiments, dependency or withdrawalsymptoms such as, but not limited to, the use of drugs in controlledsubstances, alcohol and/or drug and tobacco addiction in the medicalpatient or veterinary practice or experimental conditions such as theanimal or tissue culture.

Therefore, these therapeutic compositions form a clinical bridge beyondother advanced technologies that have not to date found a clinicalapplication with exemplary bio-safety.

1. An anabolic composition comprising: a) cartilage, chondroitinsulfate, hyaluronic acid, or collagen in an amount effective in damagedtissue to act as an anti-inflammatory and anti-neo-angiogenic agent; b)at least one polar surface active lipid selected from the groupconsisting of phosphatidic acid, phosphatidylethanolamine, lecithin,phosphatidylcholine, phosphatidylserine, phosphatidylinositol,2-lysolecithin, plasmalogen, choline plasmalogen, phosphatidylglycerol,diphosphatidylglycerol, sphingomyelin, and any combination of 2, 3, 4,5, 6, 7, 8, 9, 10, or 11 of said polar active surface lipids; c) aplurality of enantiomerically pure L-amino acids and glycine; d) taurineor L-carnitine or both taurine and L-carnitine; e) a component selectedfrom the group consisting of polyoxyethylene sorbitan monooleate,sorbitan monooleate, grape seed extract, grape extract, and combinationsthereof; and f) vitamins, minerals or trace elements selected from thegroup consisting of Vitamin B12, Vitamin E, selenium, zinc, andcombinations thereof.
 2. The composition according to claim 1, furthercomprising a compound generally recognized as safe (GRAS), said compoundbeing garlic.
 3. The composition according to claim 1, furthercomprising a flavorant.
 4. The composition according to claim 3, whereinsaid flavorant is a fruit juice.
 5. The composition according to claim4, wherein said fruit juice is tomato juice.
 6. The compositionaccording to claim 1, wherein said amino acids are L-Leucine, L-Proline,L-Arginine, L-Valine, L-Aspartic Acid, L-Isoleucine, Glycine,L-Threonine, L-Tyrosine, L-Phenylalanine, L-Serine, L-Histidine,L-Alanine, L-Cystine, L-Tryptophan, L-Methionine, L-Glutamine,L-Cysteine and L-Glutamic Acid.
 7. The composition according to claim 1,wherein said component (b) comprises soy lecithin.
 8. The compositionaccording to claim 1, wherein said composition comprises taurine.
 9. Thecomposition according to claim 1, wherein said composition comprisesL-carnitine.
 10. The composition according to claim 1, wherein saidcomposition comprises both taurine and L-carnitine.
 11. The compositionaccording to claim 1, wherein said composition further comprises omega-3fatty acids.
 12. The composition according to claim 1, wherein saidcomposition further comprises a compound generally recognized as safe(GRAS).
 13. The composition according to claim 1, wherein saidcomposition comprises phosphatidylcholine.
 14. The composition accordingto claim 1, wherein component (b) comprises lecithin.
 15. A method oftreating an inflammatory disease comprising the administration of acomposition according to claim 1 to an individual having an inflammatorydisease.
 16. The method according to claim 15, wherein said inflammatorydisease is Crohn's Disease.
 17. The method according to claim 15,wherein said inflammatory disease is inflammatory bowel disease.
 18. Amethod of treating cancer comprising the administration of a compositionaccording to claim 1 to an individual having cancer.